SA’s patent laws ‘stifle access’ to life-saving medicines

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South Africa’s patent laws are denying cancer patients access to life-saving medicines that can be bought in India for a fraction of the cost they command here, according to a study report to be released by health activists. Business Day reports that the report is to be handed over to the Department of Trade and Industry along with a detailed submission in support of its draft intellectual property policy, which was released for public comment in August.

The report says the policy contains proposals for closer scrutiny of patent applications, a simpler system for issuing compulsory licences, and mechanisms for tightening up on the criteria for granting patents, all measures supported by the Fix the Patent Laws Coalition (FTPL) because they believe they will boost competition and drive down prices. South Africa routinely grants and upholds patents on cancer medicines that could be challenged and rejected if the country had adopted stronger patentability criteria, patent examination processes and opposition procedures.

The activists’ study analysed 24 cancer medicines that have no generic competition in South Africa, and concluded 15 were available in India for less than half the private sector price in South Africa. The most extreme case was Celgene’s blood cancer drug lenalidomide, branded Revlimid, which costs R882,000 for a year’s supply in South Africa in the private sector but just R32,000 in India. This means South Africa private sector patients are paying 27 times more than those in India. The high price of the drug here has put it out of the reach of state patients.

The report says the study also highlights how easily pharmaceutical companies can extend patent protection on their products. In the case of Roche’s rituximab, branded Mabthera, the primary patent expired in South Africa in 2004, but it will be protected by secondary patents until at least 2030, or 42 years after the first patent was granted in South Africa. If a further pending patent application is approved it will be protected until 2036, said the report.

Secondary patents can include changes to the composition or formulation of a medicine or changes to its method or use. The extent of secondary patents on cancer medicines in South Africa creates legal uncertainty about their patent status, limiting generic or biosimilar competition, said the report’s authors.

The Department of Trade and Industry’s deputy director general for international trade and economic development Xolelwa Mlumbi-Peter said the draft intellectual property policy sought to find the right balance between patent protection and access to medicines. “Patents are important for innovation, economic growth and development. But you have to balance that the right to access – not only to medicines but to be able to utilise any knowledge,” she said.

She said in the report that South Africa had never granted a compulsory licence for medicines, preferring to negotiate with pharmaceutical companies instead. “We have a mechanism that works very well, in that whenever there is a challenge or an emergency, the health department speaks to the patent owner to see if they can assist, and in most cases they have been able to. The partnership has worked very well in that regard,” she said, citing HIV medicines as an example. The Health Department worked closely with the Clinton Health Access Initiative to negotiate the lowest generic HIV drug prices in the world.

Study co-author Marcus Low said: “HIV drug prices had fallen in South Africa primarily because civil society had used competition law to force drug companies to issue voluntary licences to generic manufacturers. When negotiating with pharmaceutical companies, governments should have all the legal tools allowed for under international law. If a pharmaceutical company is being unreasonable and government makes a credible threat of issuing a compulsory licence they are much more likely to come to an agreement.”

Business Day report

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